Amyotrophic Lateral Sclerosis (ALS)Phase 2NCT07142291
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
A Phase 2 study testing Cromolyn Sodium (34.2 mg BID), Cromolyn Sodium (17.1 mg BID) and Riluzole (100 mg) in people with Amyotrophic Lateral Sclerosis (ALS), run by PhenoNet, Inc. at 22 sites in 6 countries.
Trial summary
The purpose of this study is to test the effects of PHENOGENE-1A, which is the treatment under investigation in this study. This research will investigate if PHENOGENE-1A can help people with ALS by measuring their function using the ALS Functional Rating Scale Revised (ALSFRS-R), measuring lung function using… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Cromolyn Sodium (34.2 mg BID), Cromolyn Sodium (17.1 mg BID) and Riluzole (100 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 25 Nov 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ALS; the diagnosis of ALS defined by revised El Escorial criteria as follows:
- Evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological, or neuropathological examination.
- Evidence of upper motor neuron (UMN) degeneration by clinical examination.
- Progressive spread of symptoms or signs within a region or to other regions, as determined by clinical examination or the history of disease progression.
- Absence of electrophysiological, neuroimaging, or pathological evidence of other diseases that might explain the UMN or LMN degeneration and exclusion of other causes.
- Male or female subjects aged 18 to 75 years inclusive.
Show all 22Show fewer
- Must provide written informed consent for study-related procedures.
- Must be capable of completing all study-related procedures, assessments, and visits in the judgment of Investigator.
- Disease duration from ALS symptom onset of motor weakness ≤24 months.
- ALSFRS-R total score ≥38 at screening visit.
- ALSFRS-R Breathing subscore should be ≥9 at the time of screening.
- ALSFRS-R Bulbar subscore should be ≥9 at the time of screening.
- Forced vital capacity >70% of predicted value.
- PIFR ≥100 L/minute.
- Must be receiving a stable dose of standard-of-care treatment Riluzole for 4-weeks before signing informed consent.
- Female subjects who are of childbearing potential must agree to use of highly effective methods of contraception consistent with local regulations during the study, and for 3 months after the study drug administration. Examples include the following, but not limited to:
- Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives;
- Intrauterine device or intrauterine hormone-releasing system; OR
- Post-menopausal status must have experienced their last menstrual period minimum of 1 year prior to study drug administration; OR
- Surgically sterilized. Female subject should be willing to not donate egg during the trial and for 3 months after the last dose of the study drug.
- Male subjects who are sexually active with a female of childbearing potential must agree to use highly effective contraception as described above, or a combination of 2 acceptable methods of contraception (e.g., a barrier method along with a female partner using a hormonal contraceptive method), in accordance with local regulations, throughout the duration of the study, and for 3 months after the last dose of the study drug.
- (Male subject should be willing to not donate sperm during the trial and for 3 months after the last dose of the study drug.)
Who cannot join
- ALSFRS-R score change (decrease) by 2.5 or more points between the screening visit and Day 1 (baseline) score.
- Bulbar onset ALS (<9 bulbar subscore)
- Any use of non-invasive ventilation (e.g., continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation) for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
- Any other significant neurological disorder which can interfere with study assessments, e.g., significant cognitive impairment and/or clinical dementia.
- Significant psychiatric illness like schizophrenia, bipolar disorder etc. Subjects with depression can be included, only if the depression has been stable and no episode of major depression has occurred in the past year.
- Severe cardiac disease (e.g., QTc>500 ms), Torsade de Pointes, evidence of significant heart failure (New York Heart Association [NYHA] Class 3 or greater, myocardial infarction or unstable angina in the 6 months prior to screening).
Show all 15Show fewer
- Any moderate-to-severe pulmonary disease or difficulty taking inhaled drugs.
- Inability to tolerate the administration of an oral inhaled powder via DPI.
- Has taken any investigational product within 30 days or 5 half lives of the drug, whichever is longer, prior to dosing.
- Taking inhaled protein products on a chronic basis (such as insulin, parathyroid hormone, etc).
- Subjects with a body weight of 32 kg or less, or a body mass index of <17.5 or >35.0 at time of screening.
- Moderate-to-severe liver disease: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3 times the upper limit of normal; total bilirubin > 1.5 x ULN.; subjects with hepatic diseases such as hepatic cirrhosis, hepatic cancer and active hepatitis.
- Moderate-to-severe renal disease: creatinine clearance <45 mL/min/1.73 m2 (by Cockcroft-Gault calculation).
- Any clinically significant disorder or laboratory abnormality that, in the Investigator's opinion, could interfere with the subject's participation in the study, place the subject at increased risk, or confound interpretation of the study results.
- Pregnant or breast-feeding females.
Trial locations and contacts
22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 6 countries
Spain6 sites, 6 recruiting
- Recruiting
Hospital General Universitario Dr. Balmis de Alicante
Alicante, 3010
- Recruiting
Barcelona Sea Hospital (Hospital Del Mar De Barcelona)
Barcelona, 8003
- Recruiting
Hospital Universitario Vall D Hebron
Barcelona, 8035
- Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
- Recruiting
Hospital Regional Universitario De Malaga
Málaga, 29010
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
United States5 sites, 5 recruiting
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
- Recruiting
University of California San Diego
La Jolla, California, 92037
- Recruiting
Lange Neurology
New York, New York, 10065
- Recruiting
Sutter Health - California Pacific Medical Center Research Institute
San Francisco, California, 94115
- Recruiting
Honor Health Neurology - Bob Bove Neuroscience Institute
Scottsdale, Arizona, 85251
Poland4 sites, 4 recruiting
- Recruiting
Michalski i Partnerzy Lekarze Spółka Partnerska
Krakow, 31-426
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 51-503
- Recruiting
Centrum Medyczne NeuroProtect (NeuroProtect Medical Center)
Warsaw, 01-684
- Recruiting
City Clinic Research
Warsaw, 02-473
Czechia3 sites, 3 recruiting
- Recruiting
NEUROHK s.r.o.
Hradec Králové, 50002
- Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 50005
- Recruiting
Thomayer University Hospital - Fakultni Thomayerova nemocnice
Prague, 14059
Germany3 sites, 3 recruiting
- Recruiting
Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie
Berlin, 13353
- Recruiting
DIAKOVERE Henriettenstift - Klinik für Neurologie und Klinische Neurophysiologie
Hanover, 30171
- Recruiting
Universitaetsklinikum Schleswig-Holstein
Lübeck, 23538
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
About this study
Official title: A Phase IIB Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1A (Cromolyn) as an Adjuvant Treatment in Subjects With Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to test the effects of PHENOGENE-1A, which is the treatment under investigation in this study. This research will investigate if PHENOGENE-1A can help people with ALS by measuring their function using the ALS Functional Rating Scale Revised (ALSFRS-R), measuring lung function using pulmonary function tests (PFTs), such as forced vital capacity (FVC), and measuring neuro-inflammatory biomarkers in the blood.
Read the detailed description
This is a Phase IIB, randomized, double-blind, placebo-controlled study designed to assess the effects of PHENOGENE-1A (oral inhalation via dry powder inhaler [DPI]) in subjects with mild to moderate ALS disease. Eligible subjects will be randomized to receive either low dose PHENOGENE-1A (34.2 mg per day: in 2 doses of 17.1 mg and matching placebo BID), high dose PHENOGENE-1A (68.4 mg per day: 34.2 mg BID), or placebo (2 matching placebo capsules BID) (see table below), in a 2:2:1 ratio. Subjects will receive treatment for a duration of 24 weeks. All subjects must be on a stable dose of Riluzole 50 mg BID (100 mg daily) for at least 4 weeks prior to randomization and must continue their Riluzole regimen, 50 mg BID (100 mg daily), as standard-of-care treatment, throughout the 24 week treatment period.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Cromolyn Sodium (34.2 mg BID), Cromolyn Sodium (17.1 mg BID), Placebo, Riluzole (100 mg)
- Keywords
- Amyotrophic Lateral Sclerosis, Lou Gehrigs Disease, ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cromolyn Sodium (34.2 mg BID)Drug
Also called Cromolyn, Sodium Cromoglycate
17.1 mg, BID, oral inhalation
Cromolyn Sodium (17.1 mg BID)Drug
Also called Cromolyn, Sodium Cromoglycate, PHENOGENE-1A
34.2 mg, BID, oral inhalation via dry powder inhaler
PlaceboDrug
Placebo comparator matched to active treatment.
Riluzole (100 mg)Drug
Also called Rilutek
50 mg, oral tablet, BID, standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Low Dose PHENOGENE-1A (17.1 mg BID) | Experimental | 17.1 mg, BID, oral inhalation via dry powder inhaler Receives: Drug: Cromolyn Sodium (17.1 mg BID); Drug: Riluzole (100 mg) |
| High Dose PHENOGENE-1A (34.2 mg BID) | Experimental | 34.2 mg, BID, oral inhalation via dry powder inhaler Receives: Drug: Cromolyn Sodium (34.2 mg BID); Drug: Riluzole (100 mg) |
| Placebo | Placebo comparator | Placebo comparator matched to active treatment, BID, oral inhalation via dry powder inhaler Receives: Drug: Placebo; Drug: Riluzole (100 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in ALSFRS-R total score from baseline to Week 24
To evaluate the effects of PHENOGENE-1A (cromolyn) on functional changes in subjects with mild to moderate ALS using the ALS Functional Rating Scale-Revised (ALSFRS-R).
Measured: Baseline to Week 24
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To evaluate the safety of PHENOGENE-1A following 24 weeks of twice daily (BID) treatment.
Measured: Baseline to Week 24
Secondary outcomes (11)
Mean rank for CAFS at Week 24
To evaluate the effects of PHENOGENE-1A on function and survival using the Combined Assessment of Function and Survival (CAFS).
Measured: Baseline to Week 24
Time to event requiring full-time or nearly full-time respiratory support
Time from randomization to the first of 7 consecutive days on which permanent assisted ventilation (invasive or non-invasive) was used for >22 hours/day due to ALS progression.
Measured: Randomization to Week 24
Mean change in percent predicted forced vital capacity (%FVC) from baseline to Week 24
To evaluate the effect of PHENOGENE-1A on respiratory changes.
Measured: Baseline to Week 24
Mean change in peak inspiratory flow rate (PIFR) from baseline to Week 24
To evaluate changes in PIFR (L/min) during treatment.
Measured: Baseline to Week 24
Absolute Values and Changes From Baseline in Vital Signs From Baseline to Week 24 by Treatment Arm
Vital signs will include:
- Systolic blood pressure (mmHg)
- Diastolic blood pressure (mmHg)
- Pulse rate (beats per minute)
- Respiratory rate (breaths per minute)
- Body temperature (°C or °F, as recorded)
Results will be summarized as:
- Absolute values for each parameter at each scheduled visit.
- Changes from baseline at each visit.
- Summaries will be presented separately by treatment arm.
Measured: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Clinical Laboratory Values and Changes From Baseline to Week 24 by Treatment Arm
Safety laboratory assessments will include hematology, clinical chemistry, coagulation, and urinalysis panels. Each laboratory result will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant).
Results will be summarized as: Number and percentage of subjects with abnormal laboratory values at each post-baseline visit, by treatment arm.
Summary statistics for absolute values and changes from baseline at each visit.
Measured: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Physical Examination Findings From Baseline to Week 24 by Treatment Arm
The physical examination will assess head/neck, eyes, ears, nose/throat, cardiovascular, respiratory, abdominal, musculoskeletal, extremities, and skin systems. Each system will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant).
Results will be summarized as the number and percentage of subjects with abnormal findings at each post-baseline visit.
Measured: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Neurological Examination Findings From Baseline to Week 24 by Treatment Arm
The neurological examination will assess mental status, motor function, sensory function, reflexes, and coordination/cerebellar function. Each domain will be classified as normal, abnormal (not clinically significant), or abnormal (clinically significant).
Results will be summarized as the number and percentage of subjects with abnormal findings at each post-baseline visit.
Measured: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings From Baseline to Week 24 by Treatment Arm
Standard 12-lead ECGs will be performed at protocol-specified visits. Parameters assessed will include:
- Heart rate: 60-100 beats per minute (bpm)
- PR interval: 120-200 milliseconds (ms)
- QRS duration: 70-110 ms
- QT interval: < 440 ms in men, < 460 ms in women
- Corrected QT interval (QTcF, Fridericia's formula): < 450 ms in men, < 470 ms in women
Each ECG result will be classified by the investigator as normal, abnormal (not clinically significant), or abnormal (clinically significant), using these ranges as reference.
Results will be summarized as the number and percentage of subjects with abnormal ECG findings at each post-baseline visit.
Measured: Baseline to Week 24
Number and Percentage of Subjects With Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 24 by Treatment Arm
The Columbia Suicide Severity Rating Scale (C-SSRS) will be administered at protocol-specified visits to assess suicidal ideation, suicidal behavior, and self-injurious behavior without suicidal intent.
- Suicidal ideation will be captured using categories 1-5 of the C-SSRS (ranging from passive wish to be dead to active suicidal ideation with plan and intent).
- Suicidal behavior will be captured using categories 6-10 of the C-SSRS (preparatory acts, aborted attempts, interrupted attempts, and actual attempts).
- Self-injurious behavior without suicidal intent will be reported separately.
Results will be summarized as: Number and percentage of subjects with suicidal ideation, suicidal behavior, and self-injurious behavior without suicidal intent, compared between active treatment and placebo arms.
Measured: Baseline to Week 24
Number and Percentage of Subjects Who Discontinue Study Participation Due to Adverse Events From Baseline to Week 24
The incidence of study discontinuation attributed to treatment-emergent adverse events (TEAEs) will be assessed. Results will be summarized as the number and percentage of subjects who withdraw from the study due to an adverse event, presented separately by treatment arm.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start25 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PhenoNet, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142291
- Sponsor's protocol ID
- PHENOALS-001
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1A (Cromolyn) as an Adjuvant Treatment in Subjects With Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT07142291
- Acronym / sponsor ID
- PHENOALS-001
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic Lateral Sclerosis, Lou Gehrigs Disease, ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- PhenoNet, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effects of PHENOGENE-1A, which is the treatment under investigation in this study. This research will investigate if PHENOGENE-1A can help people with ALS by measuring their function using the ALS Functional Rating Scale Revised (ALSFRS-R), measuring lung function using pulmonary function tests (PFTs), such as forced vital capacity (FVC), and measuring neuro-inflammatory biomarkers in the blood.
Detailed description
This is a Phase IIB, randomized, double-blind, placebo-controlled study designed to assess the effects of PHENOGENE-1A (oral inhalation via dry powder inhaler [DPI]) in subjects with mild to moderate ALS disease. Eligible subjects will be randomized to receive either low dose PHENOGENE-1A (34.2 mg per day: in 2 doses of 17.1 mg and matching placebo BID), high dose PHENOGENE-1A (68.4 mg per day: 34.2 mg BID), or placebo (2 matching placebo capsules BID) (see table below), in a 2:2:1 ratio. Subjects will receive treatment for a duration of 24 weeks. All subjects must be on a stable dose of Riluzole 50 mg BID (100 mg daily) for at least 4 weeks prior to randomization and must continue their Riluzole regimen, 50 mg BID (100 mg daily), as standard-of-care treatment, throughout the 24 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose PHENOGENE-1A (17.1 mg BID) | Experimental | Drug: Cromolyn Sodium (17.1 mg BID), Drug: Riluzole (100 mg)17.1 mg, BID, oral inhalation via dry powder inhaler |
| High Dose PHENOGENE-1A (34.2 mg BID) | Experimental | Drug: Cromolyn Sodium (34.2 mg BID), Drug: Riluzole (100 mg)34.2 mg, BID, oral inhalation via dry powder inhaler |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Riluzole (100 mg)Placebo comparator matched to active treatment, BID, oral inhalation via dry powder inhaler |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosis of ALS; the diagnosis of ALS defined by revised El Escorial criteria as follows:
- Male or female subjects aged 18 to 75 years inclusive.
- Must provide written informed consent for study-related procedures.
- Must be capable of completing all study-related procedures, assessments, and visits in the judgment of Investigator.
- Disease duration from ALS symptom onset of motor weakness ≤24 months.
Key exclusion criteria (15 listed)
- ALSFRS-R score change (decrease) by 2.5 or more points between the screening visit and Day 1 (baseline) score.
- Bulbar onset ALS (<9 bulbar subscore)
- Any use of non-invasive ventilation (e.g., continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation) for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
- Any other significant neurological disorder which can interfere with study assessments, e.g., significant cognitive impairment and/or clinical dementia.
- Significant psychiatric illness like schizophrenia, bipolar disorder etc. Subjects with depression can be included, only if the depression has been stable and no episode of major depression has occurred in the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cromolyn Sodium (34.2 mg BID)Also: Cromolyn, Sodium Cromoglycate17.1 mg, BID, oral inhalation | Drug | High Dose PHENOGENE-1A (34.2 mg BID) |
| Cromolyn Sodium (17.1 mg BID)Also: Cromolyn, Sodium Cromoglycate, PHENOGENE-1A34.2 mg, BID, oral inhalation via dry powder inhaler | Drug | Low Dose PHENOGENE-1A (17.1 mg BID) |
| PlaceboPlacebo comparator matched to active treatment. | Drug | Placebo |
| Riluzole (100 mg)Also: Rilutek50 mg, oral tablet, BID, standard of care treatment | Drug | High Dose PHENOGENE-1A (34.2 mg BID), Low Dose PHENOGENE-1A (17.1 mg BID), Placebo |
Primary outcome
Absolute change in ALSFRS-R total score from baseline to Week 24
Time frame: Baseline to Week 24
To evaluate the effects of PHENOGENE-1A (cromolyn) on functional changes in subjects with mild to moderate ALS using the ALS Functional Rating Scale-Revised (ALSFRS-R).
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Baseline to Week 24
To evaluate the safety of PHENOGENE-1A following 24 weeks of twice daily (BID) treatment.
11 secondary outcomes
Mean rank for CAFS at Week 24
Time frame: Baseline to Week 24
Time to event requiring full-time or nearly full-time respiratory support
Time frame: Randomization to Week 24
Mean change in percent predicted forced vital capacity (%FVC) from baseline to Week 24
Time frame: Baseline to Week 24
Mean change in peak inspiratory flow rate (PIFR) from baseline to Week 24
Time frame: Baseline to Week 24
Absolute Values and Changes From Baseline in Vital Signs From Baseline to Week 24 by Treatment Arm
Time frame: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Clinical Laboratory Values and Changes From Baseline to Week 24 by Treatment Arm
Time frame: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Physical Examination Findings From Baseline to Week 24 by Treatment Arm
Time frame: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Neurological Examination Findings From Baseline to Week 24 by Treatment Arm
Time frame: Baseline to Week 24
Number and Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings From Baseline to Week 24 by Treatment Arm
Time frame: Baseline to Week 24
Number and Percentage of Subjects With Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 24 by Treatment Arm
Time frame: Baseline to Week 24
Number and Percentage of Subjects Who Discontinue Study Participation Due to Adverse Events From Baseline to Week 24
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Amyotrophic Lateral Sclerosis (ALS)
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cromolyn Sodium (34.2 mg BID), Cromolyn Sodium (17.1 mg BID) and Riluzole (100 mg) in people with Amyotrophic Lateral Sclerosis (ALS), run by PhenoNet, Inc. at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, United States, Poland, Czechia, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David R Elmaleh, PhD (+1 (617) 784-0490, delmaleh@phenonet.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in ALSFRS-R total score from baseline to Week 24 (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.